Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children

NCT05538182 | Completed DMC

• 1 other identifier: MHLS 22_63
• Study Type: interventional
• Target: 1,883
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether uncorrected or corrected long-sightedness (hyperopia) has an impact on reading skills, in Grade 2 or Grade 4 school-aged children from Mashonaland Central province of Zimbabwe, compared to age-, gender- and school-matched children with no refractive error (emmetropia), measured by the Happy Readers V4 reading tool over six months.

Conditions

Hyperopia; Long Sight

Keywords

Refractive error; Spectacle correction; Eyeglasses; Learning; School children

Outcome Measures

Primary Outcomes (8)

• Prevalence of moderate to high hyperopia (≥ +2.00D)

  The metric or method of measurement to be used:The Average of three readings(in dioptre)using cycloplegic autorefraction for each eye. Higher dioptre indicates high hyperopia

  Measured at baseline

• Binocular near visual acuity

  The metric or method of measurement to be used: Logarithm of Minimum Angle of Resolution(LogMAR) measured using the laser-etched near vision chart with Lea symbols at 12.5 cm.

  Measured at baseline

• Accommodative response

  The metric or method of measurement to be used: binocular distance autorefraction measured at 3 metres and monocular near refraction measured at 25cm using the Quick See autorefractor.

  Measured at baseline

• Presence of eye conditions

  The metric or method of measurement to be used: assessing the overall appearance of the fundus reflex in both eyes(Bruckner Reflex Test) as an indicator of the prevalence of refractive error using the Arclight ophthalmoscope. This will be a binary outcome of Yes or No.

  Measured at baseline

• Stereoacuity

  The metric or method of measurement to be used: measured in seconds of arc using the Preschool Assessment of Stereopsis with a Smile (PASS) 3+ stereoacuity test (scores: 480, 240, 120, 60, 40 and 30). Seconds of arc refers to the visual angle being measured to determine depth perception. Lower scores indicate better stereoacuity. Highest possible score: 480 Lowest possible score: 30

  Measured at baseline

• Improvement in near visual acuity on prescribing hyperopic spectacle correction

  The metric or method of measurement to be used: measured in M-unit using a conventional near vision chart with Lea symbols at 40cm.

  Measured at baseline,2 weeks and 24 weeks after baseline

• Change of reading scores 6 months post hyperopia spectacle correction

  The metric or method of measurement to be used: Reading scores measured using the Happy Readers V4 reading test. Best possible score: Improvement from baseline Worst possible score: No change from baseline

  Measured at baseline and at month -6

• Observed spectacle wear

  The metric or method of measurement to be used: proportion of children prescribed with spectacles, wearing them during unannounced direct observation

  Measured at week 6 and week 14 from baseline

Study Arms (2)

Spectacles

EXPERIMENTAL

Based on the refraction results, spectacles will be prescribed at the baseline visit and worn throughout the study. Study participants with newly diagnosed hyperopia at baseline will undergo a reading assessment and near visual acuity check over six months, compared to age-, gender- and school-matched emmetropic controls. Spectacle compliance will be observed among newly diagnosed hyperopic and newly diagnosed myopic school children in Grades 2 and 4 primary school children, from Mashonaland Central province of Zimbabwe, at six weeks and 14 weeks from spectacle acquisition.

Device: Spectacles

No treatment

NO INTERVENTION

Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months.

Interventions

Spectacles DEVICE

Based on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles.

Spectacles

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Grades 2 or 4 from the list of selected primary schools by the Ministry of Primary and Secondary Education (MoPSE)
• Primary school children will be eligible to participate in the 'reading assessment' if they fulfil the following criteria:
• Hyperopic cohort:
• In Grade 2 or 4 from the list of selected schools by the MoPSE.
• Presence of moderate to high hyperopia, defined as ≥ +2.00D in the more hyperopic meridian, in the more hyperopic eye, using cycloplegic autorefraction with an average of three consecutive readings taken.
• Emmetropic cohort:
• In Grade 2 or 4 from the list of selected schools by the MoPSE.
• Meets criteria for visually normal (unaided distance visual acuity 6/6 monocular and near visual acuity N5), based on an absence of significant refractive error.
• Presence of emmetropia, defined as \< +1.00D to \>-0.50 Dioptre in the more hyperopic meridian, in both eyes using cycloplegic autorefraction with an average of three consecutive readings taken to record the refractive status.
• Newly diagnosed hyperopic and newly diagnosed myopic children will be eligible to participate in the 'spectacle compliance' assessment if they fulfil the following criteria:
• Hyperopic cohort:
• Presence of hyperopia, defined as ≥ +2.00D in the more hyperopic meridian, in the more hyperopic eye by cycloplegic autorefraction.
• Myopic cohort:
• Presence of myopia, defined as \<-0.50D in the more hyperopic meridian, in either eye by cycloplegic autorefraction.

You may not qualify if:

• Children in either cohort will be ineligible if they have:
• History of systemic disease or ocular disease and/or medications known to have an impact on accommodation.
• History of previous spectacle wear
• Children in the hyperopic cohort will be ineligible if they have:
• Vision limitation in either eye for reasons other than hyperopia (including amblyopia defined as \<6/12 in the better eye).

Sponsors & Collaborators

• Queen's University, Belfast: lead
• L.V. Prasad Eye Institute: collaborator
• University of Zimbabwe: collaborator
• University of Ulster: collaborator
• New England College of Optometry: collaborator
• Peek Vision: collaborator
• Zimbabwe Optometric Association: collaborator
• Clearly: collaborator
• Christian Blind Mission: collaborator

Study Sites (1)

The University of Zimbabwe, Faculty of Medicine and Healthcare Sciences

Harare, P.O. Box A178, Zimbabwe

Location

Related Publications (17)

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  PMID: 25249453 BACKGROUND

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  PMID: 29801081 BACKGROUND

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  PMID: 29693366 BACKGROUND

• Narayanasamy S, Vincent SJ, Sampson GP, Wood JM. Impact of simulated hyperopia on academic-related performance in children. Optom Vis Sci. 2015 Feb;92(2):227-36. doi: 10.1097/OPX.0000000000000467.

  PMID: 25525890 BACKGROUND

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  PMID: 12939289 BACKGROUND

• O'Donoghue L, McClelland JF, Logan NS, Rudnicka AR, Owen CG, Saunders KJ. Refractive error and visual impairment in school children in Northern Ireland. Br J Ophthalmol. 2010 Sep;94(9):1155-9. doi: 10.1136/bjo.2009.176040. Epub 2010 May 21.

  PMID: 20494909 BACKGROUND

• French AN, O'Donoghue L, Morgan IG, Saunders KJ, Mitchell P, Rose KA. Comparison of refraction and ocular biometry in European Caucasian children living in Northern Ireland and Sydney, Australia. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):4021-31. doi: 10.1167/iovs.12-9556.

  PMID: 22562516 BACKGROUND

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  PMID: 23883788 BACKGROUND

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  PMID: 17299337 BACKGROUND

• Glewwe P, Park A, Zhao M. A better vision for development: Eyeglasses and academic performance in rural primary schools in China. J Dev Econ. 2016;122:170-82.

  BACKGROUND

• White SLJ, Wood JM, Black AA, Hopkins S. Vision screening outcomes of Grade 3 children in Australia: Differences in academic achievement. Int J Educ Res. 2017;83:154-9.

  BACKGROUND

• Slavin RE, Collins ME, Repka MX, Friedman DS, Mudie LI, Owoeye JO, et al. In Plain Sight: Reading Outcomes of Providing Eyeglasses to Disadvantaged Children. J Educ Stud Placed Risk. 2018;23(3):250-8.

  BACKGROUND

MeSH Terms

Conditions

Hyperopia; Refractive Errors

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Nathan G Congdon, MD, MPH

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

• Rohit C Khanna, MPH

  L.V. Prasad Eye Institute

  PRINCIPAL INVESTIGATOR

• Lynett E Masiwa, MSc

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

• Rangarirai Masanganise

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For the following objectives, all tests will be conducted by trained researchers who will be masked to the hyperopia status of the children: 1. Prevalence of moderate to high hyperopia (\>+2.00D in the more hyperopic meridian, in the more hyperopic eye, using cycloplegic autorefraction). 2. The diagnostic accuracy of four screening tools for detecting hyperopia compared to the gold standard of cycloplegic refraction. 3. The cross-sectional association between uncorrected moderate to high hyperopia and baseline reading levels (using the Happy Readers V4 tool). We will compare the results to age-, gender-and school-matched emmetropic children.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Children in Grade 2 and 4 at 16 randomly-selected primary schools in Mashonaland Central province of Zimbabwe will receive free glasses as described in the protocol.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: September 1, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: All deidentified IPD will be available from June 2022 (anticipated Trial start date) to December 2032 (inclusive of analysis, publication and archival).
• Access Criteria: Following publication of the primary outcomes there may be scope to conduct additional analyses on the data collected. In such instances formal requests for data will need to be made in writing to the Chief Investigator, who will discuss this with the Sponsor. The study will comply with the good practice principles for sharing individual participant data from publicly funded clinical trials and data sharing will be undertaken in accordance with the required regulatory requirements.

Locations

ZI (1)